Back to resultsThe Value of Diffusion-weighted Imaging in Evaluating the Early Efficacy of Liver Metastasis in Colorectal Cancer
Primary Purpose
DWI-MRI
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Diffusion weighted magnetic resonance imaging
Sponsored by
About this trial
This is an interventional device feasibility trial for DWI-MRI
Eligibility Criteria
Inclusion Criteria:
- aged ≥18 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma
- Eastern Cooperative Oncology Group performance status of 0 to 2
- life expectancy of ≥ 3 months
- at least one measurable liver metastatic lesion in MRI (≥10mm)
- have adequate bone marrow, hepatic, and renal function
- previously received no palliative chemotherapy
Exclusion Criteria:
- patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction
- patients with symptomatic brain metastases
- active clinical severe infection
- have contraindication of MRI screening
Sites / Locations
- Fudan University Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DWI-MRI
Arm Description
Outcomes
Primary Outcome Measures
Response rate
the response rate predicted by DWI-MRI
Secondary Outcome Measures
Progression free survival
Overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03088163
Brief Title
The Value of Diffusion-weighted Imaging in Evaluating the Early Efficacy of Liver Metastasis in Colorectal Cancer
Official Title
The Value of DWI-MRI(Diffusion-weighted Imaging) in Evaluating the Early Efficacy of Liver Metastasis in Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (Actual)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is designed to evaluate the value of DWI-MRI (Diffusion weighted magnetic resonance imaging) in predicting the efficacy of liver metastases after chemotherapy in colorectal cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
DWI-MRI
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DWI-MRI
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Diffusion weighted magnetic resonance imaging
Other Intervention Name(s)
DWI-MRI
Intervention Description
The enrolled colorectal liver metastases patients will receive DWI-MRI screening to evaluate the liver metastases before the chemotherapy, after the first cycle of chemotherapy and in the regular efficacy evaluation time, respectively.
Primary Outcome Measure Information:
Title
Response rate
Description
the response rate predicted by DWI-MRI
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Progression free survival
Time Frame
2 months
Title
Overall survival
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged ≥18 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma
Eastern Cooperative Oncology Group performance status of 0 to 2
life expectancy of ≥ 3 months
at least one measurable liver metastatic lesion in MRI (≥10mm)
have adequate bone marrow, hepatic, and renal function
previously received no palliative chemotherapy
Exclusion Criteria:
patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction
patients with symptomatic brain metastases
active clinical severe infection
have contraindication of MRI screening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weijian Guo
Phone
8621-64175590
Email
mingzhuhuang0718@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weijian Guo
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
ShangHai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Jian Guo
Phone
13816066360
Email
mingzhuhuang0718@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Value of Diffusion-weighted Imaging in Evaluating the Early Efficacy of Liver Metastasis in Colorectal Cancer
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